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Completed

NCT Number: NCT05392361

Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial

Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The purpose of this study is to evaluate the effect of baclofen in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability and patient satisfaction between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment).

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Key information

Conditions

Lumbar Spinal Stenosis With Nocturnal Calf Cramps Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed lumbar spinal stenosis with MRI finding
  • nocturnal calf cramps symptoms at least once per week

Exclusion criteria

  • electrolyte disorder
  • congenital muscle disease
  • muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
  • cognitive impairments

Treatment and study plan

gabapentin (neurontin® capsule 300mg) treatment

Drug

Taking gabapentin (neurontin® capsule 300mg, Pfizer) medication at night as a conservative treatment

baclofen (baclofen Tab. 10mg) treatment

Drug

Taking baclofen (baclofen Tab. 10mg, Handok co, Seoul, Korea) medication at night.

Primary outcomes

  1. Pain score

    Time frame: follow up 4 weeks

    A comparison of pain score between control (conservative management for spinal stenosis) and baclofen group (conservative management for spinal stenosis plus baclofen treatment).

    The pain score will be measured using NRS (Numeric Rating Scale) on a scale from 0-10, with 0 representing "no pain" and 10 "worst possible pain".

Secondary outcomes

  1. Frequency and severity of nocturnal calf cramps

    Time frame: follow up 4 weeks, 12 weeks

    The frequency(number) and the severity of nocturnal calf cramps that occurred in a week before each time frame will be investigated. The severity of nocturnal calf cramps will be measured by 0-4 point scale (0, no pain; 1, mild pain that disappeared immediately and tolerable; 2, moderate pain accompanied by pain enough to wake up from sleep; 3, severe pain accompanied by pain enough to wake up from sleep for a long time; 4, severe pain that lasted for a long time and affected a daily life of the next day)

  2. Insomnia severity index

    Time frame: follow up 4 weeks, 12 weeks

  3. Oswestry Disability Index

    Time frame: follow up 4 weeks, 12 weeks

  4. Patient satisfaction (PGIC)

    Time frame: follow up 4 weeks, 12 weeks

    Patient satisfaction with treatment at 12 weeks after treatment will be measured by 7-point Patient Global Impression of Change (PGIC; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 26, 2022
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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